A Study Assessing the Safety, Efficacy, and Optimum Dosage of K-161 in Subjects With Moderate to Severe Dry Eye Disease

Summary

The objective of the study is to assess the safety, efficacy, optimum dosage, and dosing regimen of K-161 in adult subjects with moderate to severe dry eye disease.

Timeline

Start

2019-08-04

Primary completion

2020-01-09

Completion

2020-01-09

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo (BID) (Vehicle) vs 0.1% K-161 (BID); p = 0.2175; ANCOVA NCT04084483 ↗

registry analysis (superiority test); Placebo (BID) (Vehicle) vs 0.1% K-161 (BID); p = 0.3852; ANCOVA NCT04084483 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	K-161	Unknown	—	—

Indications